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CompletedNCT03542552Updated Jul 28, 2021

Nifedipine Versus Magnesium Sulfate for Prevention of Preterm Labor in Symptomatic Placenta Previa

A Phase 3 interventional study of Magnesium Sulfate and Nifedipine in Placenta Previa, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants. Per ClinicalTrials.gov, last updated 2021-07-28.

Sponsored by Assiut University · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
176
Allocation
Randomized
Sex
Female
01

Study summary

Antepartum hemorrhage is defined as bleeding from or within the female genital tract, occurring from 28+0 weeks of pregnancy and till delivery of the fetus. it occurs in 3-5% of pregnancies and is an important cause of perinatal and maternal morbidity and mortality worldwide

Read the detailed description

There are many tocolytic agents may have a role in conservative management of placenta previa such as magnesium sulfate, calcium channel blockers and β-sympathormimetics. In 2004 Sharma suggests that ritodrine hydrochloride in patients with symptomatic placenta previa tends to prolong the pregnancy and result in an increase in birth weight of the babies without causing any adverse effect on the mother and fetus

02

Conditions studied

  • Placenta Previa

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03

In context

Placenta Previa

80 studies on the registry are indexed under Placenta Previa; 17 are open to participants now.

This study's enrollment of 176 is above the median of 109 across 45 interventional studies indexed under Placenta Previa.

Browse Placenta Previa studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Estimated gestational age : between 28 weeks and 37 week's gestation
  • Confirmed Placenta previa; either major or minor degrees.
  • Placenta previa with preterm uterine contractions

Exclusion criteria

Exclusion Criteria:

  • Severe attack of bleeding requiring an immediate intervention.
  • Fetal heart rates instability or non-reassuring tracing
  • Intrauterine fetal death or major fetal anomalies.
  • If associated with abruptio placentae
  • Patients with known bleeding disorders or on anticoagulant therapy
  • Patients with severe medical disorders as myasthenia gravis documented magnesium toxicity.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
176 participants (actual)

Study arms

  • Active comparator
    Nifidipne

    received oral nifedipine 10 mg every 20 minutes for three doses, followed by 10 mg orally every 6 hours

    Drug: Nifedipine

  • Experimental
    Magnisum sulphate

    Patients in the MgSO4 group received intravenous 6 g bolus MgSO4 20% followed by a 2 g/h infusion

    Drug: Magnesium Sulfate

Interventions

  • Patients received intravenous 6 g bolus MgSO4 20% followed by a 2 g/h infusion

  • received oral nifedipine 10 mg every 20 minutes for three doses, followed by 10 mg orally every 6 hours

06

What researchers measure

Primary outcomes

  1. The duration of prolongation of gestation

    measured from the time of enrollment to the time of delivery

    Time frame: 1 month

07

Study locations

1 site
  • Assiut university
    Assiut, Egypt
08

References and documents

Publications

  • Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2. PubMed 35947046 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2018 to primary completion in Mar 2021, 33 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 19, 2018
First posted
May 31, 2018
StartActual
Jun 1, 2018
Primary completionActual
Mar 30, 2021
CompletionActual
Apr 30, 2021
Last update
Jul 28, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03542552
Lead sponsor
Assiut University
Responsible party
ramy nasser (Principal investigator, Assiut University) — Principal investigator
First posted
May 31, 2018
Start date
Jun 1, 2018
Primary completion
Mar 30, 2021
Completion
Apr 30, 2021
Last update
Jul 28, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Magnesium Sulfate

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